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Arterys Cardio DL consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by Arterys Cardio DL is intended to support qualified cardiologist, radiologist, or other licensed professional healthcare practitioners for clinical decision-making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

Arterys Cardio DL is a web-accessible image post-processing analysis software device used for viewing and quantifying cardiovascular MR images. The device is intended to visualize and quantify MRI data in DICOM format. Manual and semi-automatic border detection forms the basis for analysis. The software has features for loading, saving, generating screen displays, and aggregating quantitative data from cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL is intended for use in both pediatric (neonate, infant, child and adolescent) and adult populations.

Here's an analysis of the acceptance criteria and study information for the Arterys Cardio DL device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary (K163253) for Arterys Cardio DL does not explicitly list specific quantitative acceptance criteria or their corresponding reported device performance values in a table format.
Instead, it indicates that "Safety and performance of Arterys Cardio DL has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing." The submission focuses on demonstrating substantial equivalence to predicate devices (Arterys Software v2.0 and Medis Imaging QMass) by comparing technological characteristics and asserting that it "raises no new questions of safety and effectiveness."

The "Features/Functions" table (pages 5-6) compares the proposed device's capabilities to its predicates but does not include quantitative performance metrics or acceptance criteria for those metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set.
Data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated for any test data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide information regarding the number of experts used to establish ground truth or their specific qualifications for any test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth on a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study investigating human readers' improvement with AI assistance. The focus is on the device's standalone performance and substantial equivalence to predicates.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Yes, a standalone study (algorithm-only performance) appears to have been done. The statement "Safety and performance of Arterys Cardio DL has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing" (page 7) implies that the software's inherent capabilities were tested and validated. The entire submission focuses on the algorithm's functionality and its output.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for validation. While the device provides "clinically-relevant and reproducible, quantitative data," it doesn't specify if this was validated against expert consensus, pathology, or outcomes data. Given that it's a post-processing analysis software intended to quantify existing MR images, it's highly probable that some form of expert consensus or highly accurate manual measurements served as ground truth for quantitative validation (e.g., comparing algorithm-derived volumes or flow measurements to manually delineated ones). However, this is not stated.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. Given the "DL" (Deep Learning) in the product name, it's implied that machine learning was used, which would typically involve a training set with established ground truth, but the details are absent.

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